Engineer Tech - Packaging at Arthrex Manufacturing, Inc. in Pendleton, South Carolina

Job Description:

Requisition ID: 55607 Title: Engineer Tech - Packaging Division: Arthrex Manufacturing Inc (US02) Location: Pendleton, SC

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Packaging Engineer Technician. Ideal candidates will have previous experience with BOMs and routers. Previous experience with SAP and Agile is also a plus. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

To provide technical support to AMI Packaging Engineering, Packaging Operations, Manufacturing Engineering, and INC Packaging and Design Engineering. To support projects involving: commercialization of new products; improvements in product and process performance; increases in productivity; and reduction of costs.

Essential Duties and Responsibilities:

1. Supports new product development by assisting with Packaging Design validations and Process/Equipment validations in the Laser, Passivation, Cleaning, Assembly, Packaging, Boxing, and 2nd Pack areas.


2. Develops sampling and testing plans under the direction of the area process/manufacturing engineers to support Engineering Studies and Validation protocols.


3. Supports department Process Engineers in drafting and executing validation protocols and reports (DOE/IQ/OQ/PQ) for the following processes: laser-marking, passivation, cleaning, manual and automated assembly, pouch sealing, blister sealing, and automated assembly processes.


4. Supports department Process Engineers in drafting work instructions.


5. Supports department Process Engineers with designing, procuring, assembling new tools and fixtures used in production.


6. Ensures tool and fixture drawing documentation is created/revised according to governing procedures.


7. Supports the design and maintenance of tools and fixtures: Supports Production in the control, repair tracking, and inventory of tools and fixtures. Requests quotes as needed for new tool/fixtures and/or for repairs.


8. Supports the Calibration department by identifying and locating process equipment and test instruments that require calibration.


9. Supports the Product engineers during new product and/or packaging introductions into the Packaging Department (Laser, Passivation, Cleaning, Clean Rooms, Boxing, 2nd Pack).


10. Maintains precise identification and control of validation samples and ensures information and documentation is consistently accurate.


11. Remains current with ISO/FDA/STM standards and internal quality assurance policies.

Knowledge/Skills:

• Knowledge of MS Office programs required.


• Basic ability to navigate SAP, Documentum, and Agile required.


• Ability to open and view drawing specifications.


• Knowledge of administrative procedures and computer systems such as managing files and records.


• Ability to understand engineering specifications and drawing conventions.


• A thorough knowledge of component manufacturing, product assembly, visual inspection, packaging processes, and labeling requirements.


• Knowledge of raw materials, inventory traceability, production processes, barcode scanning and labeling controls, inspection methods and equipment, and other techniques for maximizing the effective manufacturing and distribution of goods.


• Ability to execute Engineering Study protocols and document results supporting Validations.


• Ability to perform basic statistical analysis of experimental data using Statistical software (MiniTab).


• Knowledge of Packaging Testing Equipment. Able to assist sample preparation and testing (if supporting the Packaging/Sealers).


• Knowledge of Process area equipment for the area supported (eg. Packaging-sealers, automation equipment, laser-markers, passivation, cleaning).


• Expected to train operators and other trainers on competency tasks.

Education/Experience:

• High School Diploma or equivalent required.


• 3 years Manufacturing experience related to medical device manufacturing required.


• Ability to understand Drawings, Blueprints, BOM's, Routings, Validation Protocols, and DHR's required.


• Lean Manufacturing experience is preferred.


• Experience with computerized ERP and PLM systems (Oracle, SAP, Agile, etc.) preferred.


• Experience with Microsoft Office and CAD products required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.